Solid Tumours Clinical Trial
Official title:
Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden
Introduction: Many reimbursement authorities use economic evaluation to help guide decisions
regarding the adoption of new treatments in reimbursement systems. Survival and quality of
life are often the main measure of benefit used in an economic evaluation - expressed as a
quality adjusted life year (QALY). In addition though, some decision makers will also
consider the impact of a treatment on a patient's ability to continue working (expressed in
terms of productivity). The aim of the present study is to estimate quality of life weights
(utilities) and productivity loss for women with metastatic breast cancer (Human Epidermal
Growth Factor Receptor 2 positive or HER 2+).
Methods: Separate surveys will be used to assess utilities and productivity in HER2+
metastatic breast cancer (MBC). To capture utilities health state descriptions or vignettes
describing progressive disease, stable disease, and seven grade 3/4 adverse events
(diarrhoea, fatigue, anaemia, leukopenia, anorexia, decreases in left ventricular ejection
fraction (LVEF), and skin rash) will be developed. The vignettes will be developed based on
a literature review and in depth interviews with women with MBC in the Netherlands and
Sweden. Clinical experts in both countries will review the health states for content
validity. The health states will be translated using forward and back translation. Members
of the general public will rate the states (100 men and women in NL; 100 women aged 50+ in
Sweden) using the visual analogue scale and Time Trade Off method to determine utility
values. In a separate survey women who are currently being treated or have recently
completed their treatment for MBC will be surveyed regarding the impact of disease on their
ability to work using a validated work productivity measure (Work Productivity and Activity
Impairment) in women in the Netherlands and Sweden.
n/a
Time Perspective: Cross-Sectional
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03315091 -
Phase I Study to Assess the Effect of Food on AZD1775 Pharmacokinetics in Patients With Advanced Solid Tumours
|
Phase 1 | |
Completed |
NCT01921140 -
To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
|
Phase 1 | |
Completed |
NCT00732420 -
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT03572192 -
Tissue Collection Framework To Improve Outcomes In Solid Tumours
|
||
Completed |
NCT02360345 -
Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly
|
Phase 1 | |
Completed |
NCT02264418 -
Safety and Tolerability of ODM-203 in Subjects With Advanced Solid Tumours
|
Phase 1 | |
Completed |
NCT02093351 -
To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
|
Phase 1 | |
Completed |
NCT01956669 -
Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors
|
Phase 2 | |
Recruiting |
NCT02215850 -
Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
|
Phase 1 | |
Recruiting |
NCT02263950 -
A Phase 1/2a Study of LON002 in Subjects With Advanced Solid Tumours
|
Phase 1/Phase 2 | |
Completed |
NCT01931761 -
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
|
Phase 1 | |
Completed |
NCT01900028 -
To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours
|
Phase 1 | |
Completed |
NCT00136578 -
Ispinesib In Combination With Carboplatin In Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT01184274 -
A Phase I Study of SB939 in Pediatric Patients With Refractory Solid Tumours and Leukemia
|
Phase 1 | |
Withdrawn |
NCT03266159 -
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT01894256 -
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function
|
Phase 1 | |
Completed |
NCT01974349 -
To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT02923947 -
Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment
|
Phase 1 | |
Completed |
NCT02056392 -
To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT02063204 -
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects
|
Phase 1 |